MACMIROR 500 mg /200,000 Iu Suppositories

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Macmiror Complex 500 and what is it used for
3. Important information before using Macmiror Complex 500
   1. When not to use Macmiror Complex 500
   2. Warnings and precautions
   3. Using Macmiror Complex 500 in elderly patients
   4. Macmiror Complex 500 and other medicines
   5. Macmiror Complex 500 with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Macmiror Complex 500 contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
4. How to use Macmiror Complex 500
   1. Using a higher dose of Macmiror Complex 500 than recommended
   2. Stopping the use of Macmiror Complex 500
5. Possible side effects
   1. Reporting side effects
6. How to store Macmiror Complex 500
7. Contents of the packaging and other information
   1. What Macmiror Complex 500 contains
   2. What Macmiror Complex 500 looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Representative of the marketing authorization holder:
   7. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

Macmiror Complex 500, (500 mg + 200,000 IU), vaginal capsule
Nifuratel + Nystatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Macmiror Complex 500 and what is it used for
• 2. Important information before using Macmiror Complex 500
• 3. How to take Macmiror Complex 500
• 4. Possible side effects
• 5. How to store Macmiror Complex 500
• 6. Contents of the packaging and other information

1. What is Macmiror Complex 500 and what is it used for

Macmiror Complex 500 contains two active substances: nifuratel and nystatin.
Nifuratel is a synthetic compound that effectively acts against protozoa, bacteria, and fungi that most often cause vaginal infections.
Nystatin is an antibiotic with antifungal action, primarily acting on fungi of the genus Candida spp.
Indications for use of Macmiror Complex 500:

• Treatment of vaginal and vulvar infections caused by: fungi of the genus Candida spp., Trichomonas vaginalis, bacteria.

The use of nifuratel and nystatin in one medicine makes Macmiror Complex 500 effective in treating vaginal and vulvar infections caused by fungi of the genus Candida spp, Trichomonas vaginalis, and bacteria.
Nifuratel and nystatin used simultaneously are more effective in patients with fungal and other vaginal infections than each of these substances used separately. Effective treatment of vaginal infections leads to the restoration of physiological conditions and reduces the risk of future infections. The medicine does not destroy lactic acid bacteria, which play a protective role and are present in the vagina of healthy women. Nystatin and nifuratel used locally - in the vagina - do not penetrate the blood and do not affect the entire body.

2. Important information before using Macmiror Complex 500

When not to use Macmiror Complex 500

If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Macmiror Complex 500, discuss it with your doctor or pharmacist.
Like all anti-infective medicines, during long-term use of Macmiror Complex 500, an allergy may occur. If during treatment, an allergy occurs or worsens, e.g., a burning sensation, itching, the medicine should be discontinued and the doctor informed, who may change the treatment method if necessary.
During treatment, patients should not have sexual intercourse. It is recommended that the sexual partner takes nifuratel orally at the same time.
The medicine is intended for use under medical supervision.

Using Macmiror Complex 500 in elderly patients

Macmiror Complex 500 can be used by elderly patients.

Macmiror Complex 500 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions with other medicines have been reported so far.
Do not use other medicines administered vaginally, including those available without a prescription, without consulting your doctor.

Macmiror Complex 500 with food and drink

Macmiror Complex 500 can be used regardless of food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The use of Macmiror Complex 500 during pregnancy and breastfeeding is decided by the doctor.
It is not known whether the medicine passes into breast milk.
In any case, during pregnancy and breastfeeding, Macmiror Complex 500 should only be used under direct medical supervision, in a situation of absolute necessity, considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and using machines

Macmiror Complex 500 has no effect on the ability to drive and use machines.

Macmiror Complex 500 contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate

Macmiror Complex 500 may cause allergic reactions (possible late reactions).

3. How to use Macmiror Complex 500

This medicine should always be used according to the doctor's or pharmacist's recommendations.
In case of doubts, consult a doctor or pharmacist.
Macmiror Complex 500 is a vaginal capsule.
Recommended dose:
Use one capsule once a day, in the evening.
Insert the capsule deep into the vagina, in the area of the posterior vault. Ask your doctor about how to insert the capsule.
The doctor decides how long to use the medicine.
Treatment should be completed before menstruation.

Using a higher dose of Macmiror Complex 500 than recommended

Due to the route of administration and the fact that the medicine is not absorbed and does not act systemically, overdose is very unlikely.
So far, no cases of overdose have been reported.

Stopping the use of Macmiror Complex 500

Do not stop treatment without consulting your doctor, as it may be ineffective.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Macmiror Complex 500 can cause side effects, although not everybody gets them.
Very rare(may occur less frequently than 1 in 10,000 people): contact dermatitis, urticaria, vaginal burning, vaginal itching.
Vaginal burning and itching at the site of administration are usually mild and resolve on their own.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Macmiror Complex 500

Keep the medicine out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Macmiror Complex 500 contains

• The active substances of the medicine are nifuratel and nystatin. One capsule contains 500 mg of nifuratel and 200,000 IU of nystatin.
• The other ingredients are: dimethyl polysiloxane AK 1000, gelatin, glycerol, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, titanium dioxide, yellow iron oxide.

What Macmiror Complex 500 looks like and what the packaging contains

Macmiror Complex 500 is a vaginal capsule. The packaging is an Al/PVC-PVDC blister pack in a cardboard box.
8 capsules
12 capsules

Marketing authorization holder and manufacturer

Marketing authorization holder:

Polichem S.A.
50, Val Fleuri

• L-1526 Luxembourg

Manufacturer:

Doppel Farmaceutici S.r.l
Via Volturno 48
Quinto De’Stampi
20089 Rozzano (Milan)
Italy
Doppel Farmaceutici S.r.l
Via Martiri delle Foibe, 1
I-29016-Cortemaggiore – Piacenza
Italy

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel.: (22) 70 28 200
e-mail: [email protected]
The patient leaflet in a format suitable for the blind and visually impaired is available at the representative's office of the marketing authorization holder.

Date of the last update of the leaflet: